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CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)

NCT07254962 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-11-28

No results posted yet for this study

Summary

head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response.

If successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy

Conditions

  • Head Neck Cancer
  • Mouth Cancer
  • Throat Cancer
  • Larynx Cancer
  • Skin Cancer Face

Interventions

DRUG

Capecitabine

Patients will receive fixed-dose capecitabine prior to surgery

OTHER

Standard of Care (SOC)

Standard of care (no intervention until surgery)

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Lady Davis Institute

    collaborator OTHER

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Marco Mascarella, MD, MSc, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-01
Completion
2031-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254962 on ClinicalTrials.gov